| CTRI Number |
CTRI/2023/03/050746 [Registered on: 15/03/2023] Trial Registered Prospectively |
| Last Modified On: |
13/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Cold therapy as an additional aid to numb lower teeth with anesthesia in patients undergoing Root Canal Treatment. |
|
Scientific Title of Study
|
Cryotherapy as a supplementary aid to Inferior Alveolar Nerve Block in patients with Symptomatic Irreversible Pulpitis: A randomized controlled trial. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Setu Katyal |
| Designation |
Post Graduate Student |
| Affiliation |
J.N Kapoor D.A.V (C) Dental College,, Yamunanagar, Haryana. |
| Address |
Room no 3, Department of Conservative Dentistry and Endodontics, J.N Kapoor D.A.V (C) Dental College, Model Town, Yamunanagar, Haryana. 135001
Yamunanagar
HARYANA
135001
India |
| Phone |
7006465787 |
| Fax |
|
| Email |
setukatyal94jk@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Poonam Bogra |
| Designation |
Professor and Head of Department |
| Affiliation |
J.N Kapoor D.A.V (C) Dental College,, Yamunanagar, Haryana. |
| Address |
Room no 3, Department of Conservative Dentistry and Endodontics, J.N Kapoor D.A.V (C) Dental College, Model Town, Yamunanagar, Haryana. 135001
Yamunanagar
HARYANA
135001
India |
| Phone |
9050462962 |
| Fax |
|
| Email |
poonambogra@yahoo.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Setu Katyal |
| Designation |
Post Graduate Student |
| Affiliation |
J.N Kapoor D.A.V (C) Dental College,, Yamunanagar, Haryana. |
| Address |
Room no 3, Dept of Conservative Dentistry and Endodontics, J.N Kapoor D.A.V (C) Dental College, Model Town, Yamunanagar, Haryana. 135001
Yamunanagar
HARYANA
135001
India |
| Phone |
7006465787 |
| Fax |
|
| Email |
setukatyal94jk@gmail.com |
|
|
Source of Monetary or Material Support
|
| J.N Kapoor, D.A.V (C) Dental College, Yamunanagar, Haryana. 135001 |
|
|
Primary Sponsor
|
| Name |
Dr Setu Katyal |
| Address |
Room no 3, Department of Conservative Dentistry and Endodontics, J.N Kapoor D.A.V Dental College, Yamunanagar, Haryana. 135001 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Setu Katyal |
J.N Kapoor D.A.V Dental college, Yamunanagar, Haryana. |
Room no 3, Dept of Conservative Dentistry and Endodontics, J.N Kapoor D.A.V Dental college, Yamunanagar, Haryana.
Yamunanagar
HARYANA |
7006465787
setukatyal94jk@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethical Committee of J.N Kapoor D.A.V (C) Dental college , Yamunanaga |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K040||Pulpitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Inferior Alveolar Nerve Block |
Inferior Alveolar Nerve Block with 3.6 ml 2% Lignocaine (1:800000 conc) will be administered according to the technique described by Monheims and after 15 minutes , subjective and objective symptoms will be checked and Root canal treatment will be initiated. |
| Comparator Agent |
Inferior Alveolar Nerve Block along with Cryotherapy |
Inferior Alveolar Nerve Block with 3.6 ml 2% Lignocaine (1:800000 conc) will be administered according to the technique described by Monheims , after 15 minutes subjective and objective symptoms will be checked. Cryotherapy in the form of Endo Frost refrigerant spray will be applied on occlusal lingual and buccal surface of teeth (2 seconds each) and access preparation will be done immediately. The pulp will be exposed and deroofing will be done following which, sterile ice sticks (6 mm diameter and 3 cm length) will be carried with the help of a tweezer and directly placed in the pulp chamber for a period of 4 minutes. Further Root canal treatment will then be completed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients with fully formed root apex.
2.Patients with mandibular molars diagnosed with Symptomatic irreversible pulpitis.
3.Healthy patients without any significant medical disorders.
4.Patients with preoperative pain >54mm on a Heft-Parker visual analogue scale (0-170 mm)
|
|
| ExclusionCriteria |
| Details |
1.Patients allergic to or hypersensitive to local anaesthetics.
2.Patients who took any analgesics or CNS depressants during 12 hours before the treatment.
3.Patients with any systemic diseases, mental disorders, pregnancy or lactation.
4.Patients with any facial paraesthesia or any pathosis on the site of injection
5.Patients with pathologic periodontal pockets during probing.
6.Teeth with fused roots or radiographic evidence of extra root.
7.Patients who refused to give their consent for the study.
8.Patients taking any medication that could interfere with anaesthesia For eg beta blockers or antidepressants.
9.Mandibular molars showed no response to cold test, exhibiting periradicular pathosis, internal or external root resorption or with non vital pulp at access opening
10.Patients who were alcoholic.
11.Patients with unsuccessful soft tissue anaesthesia after adminstaration of IANB
12. Patients with positive response to electric pulp testing (done on maximal output at a gap of 2 minutes |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To analyze the pain score according to Heft Parker Visual analogue scale (0-170mm) and thus success of Inferior Alveolar Nerve Block with and without Cryotherapy during Root Canal Treatment in patients with Symptomatc Irreversible Pulpitis. |
At the time of ongoing procedure |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/03/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Effective pulpal anaesthesia is an important prerequisite for successful endodontic treatment. Inferior alveolar nerve block is one of the commonly employed techniques for anesthetising mandibular molars. Literature evidence shows the failure rate of IANB to be in the range of 19-56% especially in patients with symptomatic irreversible pulpitis1. In such situations, Inadequate pulpal anaesthesia may exacerbate the patient’s fear and anxiety and extend treatment time, doubting the skill of the operator . A wide range of additional methods have been employed to improve the anaesthetic efficacy of IANB in symptomatic irreversible pulpitis but of these techniques were successful in producing complete pulpal analgesia required for endodontic treatment. So the search for a more efficient technique for intra operative pain management during endodontic treatment still continues. Cryoanalgesia has been successfully used in the field of medicine for managing both acute and chronic pain Cryotherapy also induces a local anaesthetic effect by lowering the activation threshold of nociceptors and the conduction velocity of pain signals. In light of the above mentioned statements, the objective of this study is to describe the temporary anaesthetic effect or Cryoanesthesia ensued by the application of cold spray (Endo Frost) along with ice application in pulp chamber and its effectiveness as a supplementary technique for inferior alveolar nerve block in patients diagnosed with symptomatic irreversible pulpitis undergoing root canal treatment. The null hypothesis tested will be that there will be no difference between the Control group (Patients administered Inferior Alveolar Nerve Block with 2% Lignocaine) and the Cryotherapy group (Patients administered with IANB with 2% Lignocaine supplemented with cold spray and ice application). |